Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS201)

Silk Technologies

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: SDP-4 Ophthalmic Solution (1.0%); Drug: SDP-4 Ophthalmic Solution (3.0%); Drug: SDP-4 Ophthalmic Solution (0.1%); Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03889886

SDP-4-CS201

Details and patient eligibility

About

SDP-4-CS201, is a Phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular and systemic safety and efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4 ophthalmic solution will be given to parallel groups via topical ocular instillation BID.

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have DED in both eyes for ≥ 6 months prior to Visit 1/Screening.
• Total score ≥ 40 on the SANDE questionnaire.
• Tear break-up time (TBUT) of ≤ 6 seconds in both eyes.
• Anesthetized Schirmer's test tear volume ≥ 4 mm and <10 mm in both eyes.

Exclusion criteria

• Ocular surface corneal disease, other than DED.
• Lid margin disorder other than meibomian gland dysfunction (MGD).
• Any previous reconstructive or cosmetic eyelid surgery that may affect the normal function of the lids
• Any previous invasive glaucoma and/or corneal surgery
• Corneal refractive surgery in the 12 months prior to Visit 1/Screening.
• Cataract extraction within 90 days prior to Visit 1/Screening.
• Use of ophthlamic corticosteroids, NSAIDs, antibiotics, antihistamines, IOP lowering medication, in the 30 days prior to Visit 1/Screening
• Serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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305 participants in 4 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: Vehicle

SDP-4 Ophthalmic Solution (0.1%)

Experimental group

Description:

Low concentration of SDP-4

Treatment:

Drug: SDP-4 Ophthalmic Solution (0.1%)

SDP-4 Ophthalmic Solution (1.0%)

Experimental group

Description:

Mid concentration of SDP-4

Treatment:

Drug: SDP-4 Ophthalmic Solution (1.0%)

SDP-4 Ophthalmic Solution (3.0%)

Experimental group

Description:

High concentration of SDP-4

Treatment:

Drug: SDP-4 Ophthalmic Solution (3.0%)